Cohorts of 6 patients receive escalating doses of perillyl alcohol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience grade 1 toxicity or at least 1 of 6 patients experience grade 2 or greater toxicity.

Patients are followed weekly.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Study Type ICMJE

Interventional

Study Phase

Phase 1

Study Design ICMJE

Primary Purpose: Prevention

Condition ICMJE

Breast Cancer

Intervention ICMJE

Drug: perillyl alcohol

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Active, not recruiting

Enrollment ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ICMJE

DISEASE CHARACTERISTICS:

Personal history of stage Tis, I, II, or IIIA breast cancer

Previously treated with definitive resection with curative intent

Hormone receptor status:

Not specified

PATIENT CHARACTERISTICS:

Age:

Over 18

Sex:

Female

Menopausal status:

Not specified

Performance status:

ECOG 0-1

Life expectancy:

Not specified

Hematopoietic:

WBC at least 3,000/mm3

Platelet count at least 100,000/mm3

Hemoglobin at least 9.0 g/dL

Hepatic:

Bilirubin no greater than 1.5 mg/dL

AST and ALT no greater than 1.5 times upper limit of normal (ULN)

Alkaline phosphatase no greater than 1.5 times ULN

Renal:

Creatinine no greater than 1.6 mg/dL

Other:

No known malabsorption syndrome

No contraindication to perillyl alcohol

No hypersensitivity to citrus or soybean products

No non-breast malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ

No active malignancy

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

At least 6 months since prior chemotherapy

Endocrine therapy:

Concurrent adjuvant hormonal therapy allowed

Radiotherapy:

At least 6 months since prior radiotherapy

Surgery:

See Disease Characteristics

At least 6 months since prior surgery

At least 2 years since prior primary surgery

More than 4 weeks since prior surgery requiring general anesthesia, including breast reconstructive surgery

Other:

More than 3 months since prior enrollment in a single-dose study of perillyl alcohol

More than 3 months since prior enrollment in current study (at a lower dose level)